Voltarol Emulgel
500854/PL1f
500854/PL1f
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1) WHAT DICLOFENAC DIETHYLAMMONIUM EMULGEL® IS AND WHAT IT IS USED
2) BEFORE YOU USE DICLOFENAC DIETHYLAMMONIUM| EMULGEL
3) HOW TO USE DICLOFENAC DIETHYLAMMONIUM| EMULGEL
®
Diclofenac diethylammonium 1.16% w/w Emulgel
Patient Information Leaflet
The name of your medicine is Diclofenac diethylammonium 1.16% w/w Emulgel®. Throughout this leaflet it will be referred to as Diclofenac diethylammonium Emulgel®.
In this leaflet
1) What Diclofenac diethylammonium Emulgel® is and what it is used for
2) Before you use Diclofenac diethylammonium Emulgel®
3) How to use Diclofenac diethylammonium Emulgel®
4) Possible side effects
®
5) How to store Diclofenac diethylammonium Emulgel
6) Further information
Diclofenac diethylammonium Emulgel® contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Diclofenac diethylammonium Emulgel® can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
DO NOT use Diclofenac diethylammonium Emulgel® if you:
• are in the last 3 months of your pregnancy (see also pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 'What Diclofenac diethylammonium Emulgel® contains').
• have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) or ibuprofen.
Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose.
This medicine is not recommended for use in children
under 14 years of age.
Take special care with Diclofenac diethylammonium
®
Emulgel
• Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product.
• Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.
• Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight.
• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Do not use Diclofenac diethylammonium Emulgel® if you are already taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Diclofenac diethylammonium Emulgel® must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Diclofenac diethylammonium Emulgel® should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.
Diclofenac diethylammonium Emulgel® should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac diethylammonium Emulgel® should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.
Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
Driving and using machines
Diclofenac diethylammonium Emulgel®, when used as directed, is not expected to have any effect on your ability to drive or use machines.
Important information about some of the ingredients of Diclofenac diethylammonium Emulgel®
The gel formulation contains propylene, which may cause mild localised skin irritation in some people.
• Always use Diclofenac diethylammonium Emulgel® exactly as your doctor has told you.
• The gel is for external use only. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.
• Do not put Diclofenac diethylammonium Emulgel® in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce the sealing membrane of the tube with the spiked top of the cap. Do not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area 3 to 4 times a day, slowly rubbing into the skin. The amount needed will vary depending on the size of the painful or swollen area; an amount ranging in size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area where the skin is abnormal. After rubbing the gel into the skin, do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Diclofenac diethylammonium Emulgel®, unless your hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.
|4) POSSIBLE SIDE EFFECTS|
This medicine is not recommended for use in children under 14 years of age.
Do not use Diclofenac diethylammonium Emulgel® for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains, strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may wish to review your treatment regularly.
If symptoms do not improve within this time, or they get worse, consult your doctor. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
If you use more Diclofenac diethylammonium Emulgel® than you should
If you or a child accidentally swallows Diclofenac diethylammonium Emulgel®, contact your doctor or accident and emergency department immediately.
If you forget to use Diclofenac diethylammonium Emulgel®
If you miss your application of Diclofenac diethylammonium Emulgel® at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.
If you have any further questions on the use of this product, ask your pharmacist.
Like all medicines, Diclofenac diethylammonium Emulgel® can cause side effects, although not everybody gets them.
Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Diclofenac diethylammonium Emulgel®’ and tell a doctor or pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).
Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people). Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).
Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell a doctor or pharmacist).
Common side effects (may affect between 1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every
10,000 people)
The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
What Diclofenac diethylammonium Emulgel contains
The active substance is diclofenac diethylammonium 1.16% w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl capryl oca prate, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 'Important information about some of the ingredients of Diclofenac diethylammonium Emulgel®' for propylene glycol).
What Diclofenac diethylammonium Emulgel® looks like and contents of the pack
Diclofenac diethylammonium Emulgel® is a white to off white, soft, homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
Diclofenac diethylammonium 1.16% w/w Emulgel®
PL No: 18067/0296 |POM|
This leaflet was last revised on 26th October 2015. Emulgel® is a registered trademark of Novartis AG.
5) HOW TO STORE DICLOFENAC DIETHYLAMMONIUM| EMULGEL
Keep out of the sight and reach of children.
Do not store above 30°C. Protect from heat.
Do not use Diclofenac diethylammonium Emulgel® after the expiry date stated on the carton and tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
2) BEFORE YOU USE DICLOFENAC DIETHYLAMMONIUM|
|3) HOW TO USE DICLOFENAC DIETHYLAMMONIUM GEL|
Diclofenac diethylammonium 1.16% w/w Gel
Patient Information Leaflet
The name of your medicine is Diclofenac diethylammonium 1.16% w/w Gel. Throughout this leaflet it will be referred to as Diclofenac diethylammonium Gel.
In this leaflet
1) What Diclofenac diethylammonium Gel is and what it is used for
2) Before you use Diclofenac diethylammonium Gel
3) How to use Diclofenac diethylammonium Gel
4) Possible side effects
5) How to store Diclofenac diethylammonium Gel
6) Further information
1) WHAT DICLOFENAC DIETHYLAMMONIUM GEL IS AND| WHAT IT IS USED
Diclofenac diethylammonium Gel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Diclofenac diethylammonium Gel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
GEL
DO NOT use Diclofenac diethylammonium Gel if you:
• are in the last 3 months of your pregnancy (see also pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 'What Diclofenac diethylammonium Gel contains').
• have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) or ibuprofen.
Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose.
This medicine is not recommended for use in children under 14 years of age.
Take special care with Diclofenac diethylammonium Gel
• Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product.
• Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.
• Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight.
• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Do not use Diclofenac diethylammonium Gel if you are already taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Diclofenac diethylammonium Gel must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Diclofenac
diethylammonium Gel should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.
Diclofenac diethylammonium Gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac diethylammonium Gel should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.
Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
Driving and using machines
Diclofenac diethylammonium Gel, when used as directed, is not expected to have any effect on your ability to drive or use machines.
Important information about some of the ingredients of Diclofenac diethylammonium Gel
The gel formulation contains propylene glycol, which may cause mild localised skin irritation in some people.
• Always use Diclofenac diethylammonium Gel exactly as your doctor has told you.
• The gel is for external use only. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.
• Do not put Diclofenac diethylammonium Gel in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce the sealing membrane of the tube with the spiked top of the cap. Do not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area 3 to 4 times a day, slowly rubbing into the skin. The amount needed will vary depending on the size of the painful or swollen area; an amount ranging in size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area where the skin is abnormal. After rubbing the gel into the skin, do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Diclofenac diethylammonium Gel, unless your hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children under 14 years of age.
|4) POSSIBLE SIDE EFFECTS|
Do not use Diclofenac diethylammonium Gel for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains, strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may wish to review your treatment regularly.
If symptoms do not improve within this time, or they get worse, consult your doctor. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
If you use more Diclofenac diethylammonium Gel than you should
If you or a child accidentally swallows Diclofenac diethylammonium Gel, contact your doctor or accident and emergency department immediately.
If you forget to use Diclofenac diethylammonium Gel
If you miss your application of Diclofenac diethylammonium Gel at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.
If you have any further questions on the use of this product, ask your pharmacist.
Like all medicines, Diclofenac diethylammonium Gel can cause side effects, although not everybody gets them.
Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Diclofenac diethylammonium Gel and tell a doctor or pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).
Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people).
Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).
Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell a doctor or pharmacist).
Common side effects (may affect between 1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every
10,000 people)
The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
What Diclofenac diethylammonium Gel contains
The active substance is diclofenac diethylammonium 1.16% w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl capryl oca prate, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 'Important information about some of the ingredients of Diclofenac diethylammonium Gel' for propylene glycol).
What Diclofenac diethylammonium Gel looks like and contents of the pack
Diclofenac diethylammonium Gel is a white to off white, soft, homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
Diclofenac diethylammonium 1.16% w/w Gel
PL No: 18067/0296 |POM|
This leaflet was last revised on 26th October 2015.
5) HOW TO STORE DICLOFENAC DIETHYLAMMONIUM|
GEL
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
Do not use Diclofenac diethylammonium Gel after the expiry date stated on the carton and tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
®
3) HOW TO USE VOLTAROL® EMULGEL
®®
Voltarol® Emulgel®
(diclofenac diethylammonium) Patient Information Leaflet
In this leaflet
1) What Voltarol® Emulgel® is and what it is used for
2) Before you use Voltarol® Emulgel®
3) How to use Voltarol® Emulgel®
4) Possible side effects
5) How to store Voltarol® Emulgel®
6) Further information
1) WHAT VOLTAROL® EMULGEL® IS AND WHAT IT IS
USED FO
Voltarol® Emulgel® contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Voltarol® Emulgel® can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
2) BEFORE YOU USE VOLTAROL® EMULGEL
DO NOT use Voltarol® Emulgel® if you:
• are in the last 3 months of your pregnancy (see also pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 'What Voltarol® Emulgel® contains').
• have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) or ibuprofen.
Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose.
This medicine is not recommended for use in children under 14 years of age.
Take special care with Voltarol® Emulgel®
• Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product.
• Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.
• Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight.
• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Voltarol® Emulgel® must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Voltarol® Emulgel® should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.
Voltarol® Emulgel® should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltarol® Emulgel® should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.
Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
Driving and using machines
Voltarol® Emulgel®, when used as directed, is not expected to have any effect on your ability to drive or use machines.
Important information about some of the ingredients of Voltarol® Emulgel®
The gel formulation contains propylene glycol, which may cause mild localised skin irritation in some people.
Always use Voltarol Emulgel exactly as your doctor has told you.
The gel is for external use only. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.
Do not put Voltarol® Emulgel® in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce the sealing membrane of the tube with the spiked top of the cap. Do not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area 3 to 4 times a day, slowly rubbing into the skin. The amount needed will vary depending on the size of the painful or swollen area; an amount ranging in size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area where the skin is abnormal. After rubbing the gel into the skin, do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Voltarol® Emulgel®, unless your hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children under 14 years of age.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Do not use Voltarol® Emulgel® if you are already taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).
can cause side effects,
Do not use Voltarol® Emulgel® for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains, strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may wish to review your treatment regularly.
If symptoms do not improve within this time, or they get worse, consult your doctor. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
If you use more Voltarol® Emulgel® than you should
If you or a child accidentally swallows Voltarol® Emulgel®, contact your doctor or accident and emergency department immediately.
If you forget to use Voltarol® Emulgel®
If you miss your application of Voltarol® Emulgel® at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.
If you have any further questions on the use of this product, ask your pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Voltarol Emulgel although not everybody gets them.
Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Voltarol® Emulgel® and tell a doctor or pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).
Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people).
Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).
Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell a doctor or pharmacist).
What Voltarol® Emulgel® contains
The active substance is diclofenac diethylammonium 1.16% w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl capryl oca prate, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 'Important information about some of the ingredients of Voltarol® Emulgel®' for propylene glycol).
What Voltarol® Emulgel® looks like and contents of the pack
Voltarol® Emulgel® is a white to off white, soft, homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
Voltarol® Emulgel® _
PL No: 18067/0296 |POM|
This leaflet was last revised on 26th October 2015.
Voltarol® and Emulgel® are registered trademarks of Novartis AG.
Common side effects (may affect between 1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every
10,000 people)
The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5) HOW TO STORE VOLTAROL® EMULGEL®
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
Do not use Voltarol® Emulgel® after the expiry date stated on the carton and tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Read all of this leaflet carefully because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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3) HOW TO USE VOLTAREN® EMULGEL
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Voltaren® Emulgel® (diclofenac diethylammonium) Patient Information Leaflet
In this leaflet
1) What Voltaren® Emulgel® is and what it is used for
2) Before you use Voltaren® Emulgel®
3) How to use Voltaren® Emulgel®
4) Possible side effects
5) How to store Voltaren® Emulgel®
6) Further information
1) WHAT VOLTAREN® EMULGEL® IS AND WHAT IT IS
USED FO
Voltaren® Emulgel® contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is specially formulated for rubbing into the skin and used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Voltaren® Emulgel® can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.
2) BEFORE YOU USE VOLTAREN® EMULGEL
DO NOT use Voltaren Emulgel if you:
• are in the last 3 months of your pregnancy (see also pregnancy and lactation section)
• have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 'What Voltaren® Emulgel® contains').
• have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) or ibuprofen.
Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose.
This medicine is not recommended for use in children under 14 years of age.
Take special care with Voltaren® Emulgel®
• Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product.
• Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.
• Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight.
• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Voltaren® Emulgel® must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Voltaren® Emulgel® should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.
Voltaren® Emulgel® should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltaren® Emulgel® should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.
Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
Driving and using machines
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Voltaren Emulgel , when used as directed, is not expected to have any effect on your ability to drive or use machines.
Important information about some of the ingredients of Voltaren® Emulgel®
The gel formulation contains propylene glycol, which may cause mild localised skin irritation in some people.
Always use Voltaren Emulgel exactly as your doctor has told you.
The gel is for external use only. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.
Do not put Voltaren® Emulgel® in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
Adults
1. Take the tube out of the carton. Before first use, pierce the sealing membrane of the tube with the spiked top of the cap. Do not use if seal is broken.
2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area 3 to 4 times a day, slowly rubbing into the skin. The amount needed will vary depending on the size of the painful or swollen area; an amount ranging in size from a 1 penny to a 2 pence piece will usually be sufficient.
You may notice a slight cooling effect when you rub the gel in.
3. Do not rub the gel into cuts, open wounds or any other area where the skin is abnormal. After rubbing the gel into the skin, do not cover with bandages or sticking plaster.
4. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
5. Wash your hands after rubbing in Voltaren® Emulgel®, unless your hands are the site being treated. Replace the cap.
6. Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.
This medicine is not recommended for use in children under 14 years of age.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Do not use Voltaren® Emulgel® if you are already taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).
can cause side effects,
Do not use Voltaren® Emulgel® for more than:
• 2 weeks for muscle and joints injuries (e.g. sprains, strains, bruises) or tendonitis.
• If you are using the gel for arthritis, your doctor may wish to review your treatment regularly.
If symptoms do not improve within this time, or they get worse, consult your doctor. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
If you use more Voltaren® Emulgel® than you should
If you or a child accidentally swallows Voltaren® Emulgel®, contact your doctor or accident and emergency department immediately.
If you forget to use Voltaren® Emulgel®
If you miss your application of Voltaren® Emulgel® at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.
If you have any further questions on the use of this product, ask your pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Voltaren® Emulgel® although not everybody gets them.
Some rare and very rare side effects might be serious
If you experience any of the following signs of allergy,
STOP using Voltaren® Emulgel® and tell a doctor or pharmacist immediately:
Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).
Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people).
Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).
Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell a doctor or pharmacist).
What Voltaren® Emulgel® contains
The active substance is diclofenac diethylammonium 1.16% w/w corresponding to 1% w/w diclofenac sodium.
The other ingredients are: diethylamine, carbomer, cocyl capryl oca prate, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol, cetomacrogol 1000 and deionised water (see end of Section 2 'Important information about some of the ingredients of Voltaren® Emulgel®' for propylene glycol).
What Voltaren® Emulgel® looks like and contents of the pack
Voltaren® Emulgel® is a white to off white, soft, homogeneous, cream-like, aqueous, emulsion gel.
It comes in a 100 g tube.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Novartis Consumer Health SA, Basle, Switzerland.
Voltaren® Emulgel® _
PL No: 18067/0296 |POM|
This leaflet was last revised on 26th October 2015.
Voltaren® and Emulgel® are registered trademarks of Novartis AG.
Common side effects (may affect between 1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin
Very rare side effects (may affect less than 1 in every
10,000 people)
The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5) HOW TO STORE VOLTAREN® EMULGEL®
Keep out of the sight and reach of children.
Do not store above 30°C.
Protect from heat.
Do not use Voltaren® Emulgel® after the expiry date stated on the carton and tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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